XNK Receives EU Tissue Establishment Certificate
XNK Therapeutics today announced that it has been approved as an EU Tissue Establishment. This certificate allows the company to take control of the complete manufacturing chain, from withdrawal of blood from the patient at the clinic to the delivery of the finished autologous NK-cell based medicinal product.
“This is another very important milestone for us. From a manufacturing viewpoint, we now have all the permits we need to launch clinical studies within EU. All building blocks are now completed to position us for significant value creation with three to four potential phase I/II readouts in our pipeline over the coming three years,” said Johan Liwing, CEO of XNK Therapeutics.
Earlier in March 2023, XNK received a certificate of GMP compliance of a manufacturer from the Swedish Medical Products Agency, which means that the company can produce at scale for its planned clinical studies. XNK’s pipeline is spearheaded by a clinical phase II program in multiple myeloma and the current preclinical programs are within urothelial cancer and acute myeloid leukemia (AML).
“I am proud of the work of our team. This shows our strength as a company to involve representatives from our clinical and manufacturing departments working cross-functional to incorporate an additional layer to our quality management system. I can now with confidence say that XNK can handle both the patient blood and personal data in a secure manner, ensuring patient safety and integrity. This enables us of in-house manufacturing of ATMPs for future clinical trials. This is an important step in the company’s ambitious growth plan to enable further larger clinical trials with our natural killer cell-based therapies,” said Linda Brink, Head of QA at XNK Therapeutics.
The building phase of the company’s new GMP clean room facility was completed in September 2022. The GMP facility comprises approximately 350 square meters and is located at XNK in the Novum Research Park, co-located with the Karolinska Institutet and the Karolinska University Hospital in Huddinge, Sweden.
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